Before a new drug can be marketed in the United States, clinical research must be conducted to prove the safety and efficacy of the drug. Typically, the safety and efficacy of a new drug is determined by statistical analysis of trial data collected during the clinical research phase of new drug development. The statistical analysis depends on the accuracy of the data being analyzed. Typically, trial data is manually recorded by clinical researchers on case report forms. The data on the case report forms must then be compiled before statistical analysis can be done.
The process of compiling clinical trial data for statistical analysis is paper intensive. A typical study may include thousands of case report forms. The case report forms are distributed among many users for processing the case report forms. In most data management systems, each user performs a specified task and then passes the case report forms to the next user which performs another specified task. The case report forms are passed from one user to another in this manner until processing is complete. One or more of the users enter the data contained in the case report forms into a database maintained on a computer.
The paper intensive processes used for scientific data management in the past were designed to insure the quality and integrity of the scientific database so that a reliable analysis could be made. However, these paper intensive processes have some disadvantages. First, fairly elaborate tracking systems must be created to track the case report forms as they are moved from one user to the next. Normally, a separate tracking database is used to keep track of documents as they are processed. At each step of the process, the tracking database must be updated to reflect the current disposition and location of the document. Maintaining these tracking systems can be time consuming and cumbersome.
Another disadvantage of paper systems is that they are labor intensive. For example, distribution of the case report forms is accomplished by manually moving the case report forms from one user to the next. As a result, support personnel must be hired for handling the case report forms. These support personnel are not directly involved in the data processing.
Another disadvantage of paper systems is that access to a case report form is limited to a single user at a time. That is, only one user at a time possesses the case report form. If another user needs access to the case report form, the other user would have to wait until processing of that case report form is complete, or make a special request to remove the case report form from the processing stream. Removing the case report form from the processing stream increases the complexity of document tracking.